(130) DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
37 CFR Part 1
[Docket No. 010208033-1033-01]
RIN 0651-AB33
Changes to the Time Period for
Making any Necessary Deposit of
Biological Material
AGENCY: United States Patent and Trademark Office,
Commerce.
ACTION: Final rule.
SUMMARY: In a rulemaking to implement the Patent
Business Goals, the United States Patent and Trademark Office (Office)
proposed a change to the time period within which a deposit of
biological material (if needed) must be made. The Office held this
proposed change in abeyance pending consideration of a study by the
Comptroller General of the potential risks to the United States
biotechnology industry relating to biological deposits as required by
the American Inventors Protection Act of 1999. The Office is now, after
consideration of this study, adopting a change to the time period
within which a deposit of biological material (if needed) must be made
and the depository information added to the specification.
EFFECTIVE DATE: This change is effective for any
application in which a Notice of Allowability is mailed on or after
June 21, 2001.
FOR FURTHER INFORMATION CONTACT: Robert W. Bahr, Karin
L. Tyson, or Robert A. Clarke by telephone at (703) 308-6906, or by
mail addressed to: Box Comments - Patents, Commissioner for Patents,
Washington, D.C. 20231, or by facsimile to (703) 872-9411, marked to
the attention of Robert W. Bahr.
SUPPLEMENTARY INFORMATION: In October of 1999, the
Office proposed a number of changes to the rules of practice in title
37 of the Code of Federal Regulations to implement the Patent Business
Goals. See Changes to Implement the Patent Business Goals,
64 FR 53771 (Oct. 4, 1999), 1228 Off. Gaz. Pat. Office 15
(Nov. 2, 1999) (Proposed Rule). Among the proposed changes was a
proposal to amend 1.809 to revise the time period within which a
deposit of biological material (if needed) must be made and the
depository information added to the specification. See Changes to
Implement the Patent Business Goals, 64 FR 53814, 53842, 1228
Off. Gaz. Pat. Office 52, 78-79.
The American Inventors Protection Act of 1999 (Title IV of the
Intellectual Property and Communications Omnibus Reform Act of 1999 (S.
1948) as introduced in the 106th Congress on November 17, 1999) was
incorporated and enacted into law on November 29, 1999, by
1000(a)(9), Division B, of Pub. L. 106-113, 113 Stat. 1501 (1999).
Section 4805 of the American Inventors Protection Act of 1999 provides
that the Comptroller General (in consultation with the Office) shall
conduct a study and submit a report to Congress on the potential risks
to the United States biotechnology industry relating to deposits of
biological material in support of biotechnology patents, and that the
Office shall consider the recommendations of such study in drafting
regulations affecting deposits of biological material (including any
modification of 1.801 et seq.). Therefore, the Office
held its proposed change to 1.809 in abeyance pending the completion
of the study. See Changes to Implement the Patent Business
Goals, 65 FR 54603, 54651 (Sept. 8, 2000), 1238 Off. Gaz.

Pat. Office 77, 118-19 (Sept. 19, 2000) (Final Rule).
The study required by 4805 of the American Inventors
Protection Act of 1999 was completed in October of 2000. See
Deposits of Biological Materials in Support of Certain Patent
Applications, GAO-01-49 (Oct. 2000). This report may be obtained:
(1) by mail addressed to U.S. General Accounting Office, P.O. Box
37050, Washington, D.C. 20013; (2) in person by visiting Room 1100, 700
4th Street, N.W. (Corner of 4th Street and G Street, N.W.), U.S.
General Accounting Office, Washington, D.C., (3) by telephone at (202)
512-6000, facsimile at (202) 512-6061, or TDD (202) 512-2537; or (4)
via the General Accounting Office's Internet Web site at
http://www.gao.gov. The study did not contain any recommendations
related to the Office's proposal to amend 1.809 to revise the time
period within which a deposit of biological material (if needed) must
be made. Therefore, the Office is now revising 1.809 based upon its
October 1999 proposal.
Discussion of Specific Rules
Title 37 of the Code of Federal Regulations, Part 1, is amended
as follows:
Section 1.136: Section 1.136(c) is amended to add the
period for making a deposit set under 1.809(c) to the time periods
that are not extendable under 1.136 if an applicant is notified in a
"Notice of Allowability" that an application is otherwise in
condition for allowance, or in an Office action having a mail date on
or after the mail date of the "Notice of Allowability."
Section 1.809: Section 1.809(b) is amended to change
"respond" to "reply" (see 1.111), and to
eliminate the language relating to payment of the issue fee.
Section 1.809(c) is amended to: (1) provide that if an
application for patent is otherwise in condition for allowance except
for a needed deposit and the Office has received a written assurance
that an acceptable deposit will be made, applicant will be notified and
given a period of time within which the deposit must be made in order
to avoid abandonment; (2) provide that this time period is
not extendable under 1.136(a) or (b) if set forth in a
"Notice of Allowability" or in an Office action having a mail date
on or after the mail date of a "Notice of Allowability"
(see 1.136(c)); and (3) eliminate the language stating
that failure to make a needed deposit will result in abandonment for
failure to prosecute, because abandonment for failure to prosecute
occurs by operation of law when an applicant fails to timely comply
with such a requirement (see 35 U.S.C. 133). If an
application for patent is otherwise in condition for allowance except
for a needed deposit, the Office will notify applicant in the "Notice
of Allowability" that a deposit is required, and the "Notice of
Allowability" will set a three-month (non-extendable) period within
which the deposit must be made in order to avoid abandonment of the
application.
Section 1.809(e) is added to remind applicants that the amendment
required by 1.809(d) must be filed before or with the payment of the
issue fee. The rules of practice no longer permit amendments to be
filed after payment of the issue fee. See 1.312.
Therefore, applicants need to make any necessary deposit of biological
material well prior to payment of the issue fee such that the accession
number is received with sufficient time remaining to amend the
specification as required by 1.809(d) on or before the date the
issue fee is paid. If the amendment required by 1.809(d) is not
filed before or with the payment of the issue fee, applicant will need
to submit the amendment with a petition under 1.183 to waive the

requirement of 1.312 that any amendment after the mailing of a
notice of allowance be filed before or with the payment of the issue
fee so as to permit entry of the amendment required by 1.809(d).
Finally, applicants are encouraged to make the deposit when
filing the patent application in order to avoid possible loss of the
U.S. filing date in other countries. See Manual of Patent
Examining Procedure 2406.03 (July 1998).
Classification
Administrative Procedure Act: This final rule only
changes the time period within which a deposit under 1.801 et
seq. must be filed (if needed). Therefore, this change concerns
only rules of Office procedure, and prior notice and an opportunity for
public comment for this change is not required pursuant to 5 U.S.C.
553(b)(A), or any other law. However, a notice of proposed rulemaking
was published in the Federal Register and the Official Gazette, and no
comments on the proposed change were received. See Changes to
Implement the Patent Business Goals, 64 FR 53771 (Oct. 4, 1999),
1228 Off. Gaz. Pat. Office 15 (Nov. 2, 1999) (Proposed
Rule).
Regulatory Flexibility Act: The Assistant General
Counsel for Legislation and Regulation of the Department of Commerce
certified to the Chief Counsel for Advocacy of the Small Business
Administration that this rule will not have a significant economic
impact on a substantial number of small entities. No comments were
received regarding the economic impact of this rule. As a result, no
regulatory flexibility analysis was prepared.
Executive Order 13132: This final rule does not
contain policies with federalism implications sufficient to warrant
preparation of a Federalism Assessment under Executive Order 13132
(August 4, 1999).
Executive Order 12866: This final rule has been
determined to be not significant for purposes of Executive Order 12866
(September 30, 1993).
Paperwork Reduction Act: This final rule involves
information collection requirements which are subject to review by the
Office of Management and Budget (OMB) under the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.). The collection of
information involved in this final rule has been reviewed and
previously approved by OMB under the following control number
0651-0022. The United States Patent and Trademark Office is not
resubmitting an information collection package to OMB for its review
and approval because the changes in this final rule do not affect the
information collection requirements associated with the information
collection under OMB control number 0651-0022.
The title, description and respondent description of this
information collection is shown below with an estimate of the annual
reporting burdens. Included in the estimate is the time for reviewing
instructions, gathering and maintaining the data needed, and completing
and reviewing the collection of information. The principal impact of
the changes in this final rule is a change in the time period for
filing a deposit under 1.801 et seq. (if needed).
OMB Number: 0651-0022.
Title: Deposit of Biological Materials for Patent Purposes.
Form Numbers: None.
Type of Review: Routine submission.
Affected Public: Individuals or Households, State or Local
Governments, Farms, Business or Other For-Profit, Federal Agencies or

Employees, Not-for-Profit Institutions, Small Businesses or Organizations.
Estimated Number of Respondents: 3,300.
Estimated Time Per Response: 1.0 hour.
Estimated Total Annual Burden Hours: 3,300 hours.
Needs and Uses: Information on depositing of biological materials
in depositories is required for (1) Office determination of compliance
with the patent statute where the invention sought to be patented relies
on biological material subject to deposit requirement, which includes
notifying interested members of the public where to obtain samples of
deposits, and (2) depositories desiring to be recognized as suitable by
the Office.
Comments are invited on: (1) whether the collection of
information is necessary for proper performance of the functions of the
agency; (2) the accuracy of the agency's estimate of the burden; (3)
ways to enhance the quality, utility, and clarity of the information to
be collected; and (4) ways to minimize the burden of the collection of
information to respondents.
Interested persons are requested to send comments regarding these
information collections, including suggestions for reducing this
burden, to Robert J. Spar, Director, Office of Patent Legal
Administration, United States Patent and Trademark Office, Washington,
D.C. 20231, or to the Office of Information and Regulatory Affairs,
OMB, 725 17th Street, N.W., Washington, D.C. 20503, (Attn: PTO Desk
Officer).
Notwithstanding any other provision of law, no person is required
to respond to nor shall a person be subject to a penalty for failure to
comply with a collection of information subject to the requirements of
the Paperwork Reduction Act unless that collection of information
displays a currently valid OMB control number.
List of Subjects
37 CFR Part 1
Administrative practice and procedure, Courts, Freedom of
Information, Inventions and patents, Reporting and record keeping
requirements, Small Businesses.
For the reasons set forth in the preamble, 37 CFR Part 1 is
amended as follows:
PART 1 - RULES OF PRACTICE IN PATENT CASES
I. The authority citation for 37 CFR Part 1 continues to read as
follows:
Authority: 35 U.S.C. 2(b)(2).
. Section 1.136 is amended by revising paragraph (c) to read as
follows:
1.136 Extensions of time.
* * * * *
(c) If an applicant is notified in a "Notice of Allowability" that an
application is otherwise in condition for allowance, the following time
periods are not extendable if set in the "Notice of Allowability" or in
an Office action having a mail date on or after the mail date of the
"Notice of Allowability":
(1) The period for submitting an oath or declaration in
compliance with 1.63;
(2) The period for submitting formal drawings set under 1.85(c); and

(3) The period for making a deposit set under 1.809(c).
. Section 1.809 is amended by revising paragraphs (b) and (c)
and adding paragraph (e) to read as follows:
1.809 Examination procedures.
* * * * *
(b) The applicant for patent or patent owner shall reply to a
rejection under paragraph (a) of this section by -
(1) In the case of an applicant for patent, either making an acceptable
original, replacement, or supplemental deposit, or assuring the Office
in writing that an acceptable deposit will be made; or, in the case of
a patent owner, requesting a certificate of correction of the patent
which meets the terms of paragraphs (b) and (c) of 1.805, or
(2) Arguing why a deposit is not needed under the circumstances of the
application or patent considered and/or why a deposit actually made
should be accepted. Other replies to the examiner's action shall be
considered nonresponsive. The rejection will be repeated until either
paragraph (b)(1) of this section is satisfied or the examiner is
convinced that a deposit is not needed.
(c) If an application for patent is otherwise in condition for
allowance except for a needed deposit and the Office has received a
written assurance that an acceptable deposit will be made, applicant
will be notified and given a period of time within which the deposit
must be made in order to avoid abandonment. This time period is not
extendable under 1.136(a) or (b) if set forth in a "Notice of
Allowability" or in an Office action having a mail date on or after
the mail date of a "Notice of Allowability" (see 1.136(c)).
* * * * *
(e) Any amendment required by paragraphs (d)(1), (d)(2) or (d)(4) of
this section must be filed before or with the payment of the issue fee
(see 1.312).
April 18, 2001 NICHOLAS P. GODICI
Acting Under Secretary of Commerce for
Intellectual Property and Director of the
United States Patent and Trademark Office
[1246 OG 104]